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Hi Experts,
I would like to get a better idea on how to CE mark a medical product consisting of multiple components. As an example: a laser focusing hand piece consisting of a hand piece body, different focusing lenses, different sleeves matching in length with the focal length of the lenses.
Conformity assessment is performed with all the components. A final product is configured by the user. When he is ordering a focusing hand piece with a focal length of - let me say 20 mm and 40 mm, he will receive a ready assembled focusing hand piece and in addition an extra lense and a compatible sleeve. In the definition of the MDD the lense and sleeves are accessories and should be classified independent of the final product. However - what is the classification of a lense or a sleeve? And - in addition to it - what is about the marking? Shall all components carry a CE mark or just the Main Product?
Next Example:
A laparoscopic instrument which is dismountable for cleaning reasons. You may find an outer shaft, an inner shaft, a luer-lock connector and a closing cap for a luer connector. In addition you may have different insert tubings and a distal actuator. The user may use it with or without an inner shaft, may use different actuators and so on. How to mark the instrument and what is about the classification of the components?
Simple Question:
What is about a closing cap for a luer-lock connector? It is an accessory in my understanding and so would have to be classified separately? This seems very strange to me - and what is about the CE mark? Does it have to have a CE mark?
Thank you all for your qualified comments and proposals.
Bernhard
I would like to get a better idea on how to CE mark a medical product consisting of multiple components. As an example: a laser focusing hand piece consisting of a hand piece body, different focusing lenses, different sleeves matching in length with the focal length of the lenses.
Conformity assessment is performed with all the components. A final product is configured by the user. When he is ordering a focusing hand piece with a focal length of - let me say 20 mm and 40 mm, he will receive a ready assembled focusing hand piece and in addition an extra lense and a compatible sleeve. In the definition of the MDD the lense and sleeves are accessories and should be classified independent of the final product. However - what is the classification of a lense or a sleeve? And - in addition to it - what is about the marking? Shall all components carry a CE mark or just the Main Product?
Next Example:
A laparoscopic instrument which is dismountable for cleaning reasons. You may find an outer shaft, an inner shaft, a luer-lock connector and a closing cap for a luer connector. In addition you may have different insert tubings and a distal actuator. The user may use it with or without an inner shaft, may use different actuators and so on. How to mark the instrument and what is about the classification of the components?
Simple Question:
What is about a closing cap for a luer-lock connector? It is an accessory in my understanding and so would have to be classified separately? This seems very strange to me - and what is about the CE mark? Does it have to have a CE mark?
Thank you all for your qualified comments and proposals.
Bernhard